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Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
2015
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Batch 170808-29
Exp Date 28/08/2019
Assay > 99%
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
16 +/- 0,5 mcl

NEGATIVE CONTROL
16 +/- 0,5 mcl

POSITIVE CONTROL
16 +/- 0,5 mcl
Duration of treatment / exposure:
42 h
Number of replicates:
3
Irritation / corrosion parameter:
% tissue viability
Value:
ca. 68.5
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 439:2015, under the test conditions applied, the test substance is considered NON IRRITANT
Executive summary:

The test was carried out using reconstructed human epidermis (RHE), in triplicate. The exposure of the insert to the test substance was carried out for 42 in at room temperature.

After treatment the inserts were rinsed with D-PBS and post-incubated with growth medium for additional 42 hours at 37 +/- 1°C, 5 +/-% CO2. Finally, inserts were incubated with MTT solution in oredr to evaluate cell viability which is a direct measure of the irritant potential of the substance. Because of the MTT - reducing interference produced by the test substance, additional testing were performed to evaluate the correct irrititant potential. Under these conditions, the test substance Benzyl Glycol CAS 622 -08 -2 assay >99% resulted NON IRRITANT

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
Version / remarks:
2018
Deviations:
no
GLP compliance:
yes
Species:
human
Controls:
yes, concurrent no treatment
yes, concurrent negative control
Irritation parameter:
other: TISSUE VIABILITY
Value:
ca. 4.04
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Under the test method and test conditions employed the tissues treated with test item benzyl glycol showed a relative percent viability < 60 % hence, it is concluded that the test item was Irritant. According to the test method , the test substance is considered as requiring further testing for resolving between UN GHS categories 1 and 2.
Executive summary:

The test substance Benzyl Glycok CAS 622 -08 -2 Assay > 99% was subjected to occular irritation assay, conducted according to OECD 492:2018. The test was carried out using Reconstructed human cornea-like Epithelium (RhCE), in duplicate. The exposure of the insert to the test substance was carried out for 30 minutes at 37 +/- 1°C, 5 +/- 1% CO2. After treatment the inserts were rinsed with D-PBS and incubated for 12 minutes at room temperature. Then the inserts were post incubated with assay medium for addtional 120 minutes at 37 +/- 1°C, 5 +/- 1% CO2. Finally, insertes were incubated with MTT solution in order to evaluate cell viability which is a direct measure of the irritant potential of the test substance. Under these conditions, the test substance is identified as requiring further testing for resolving between UN GHs Cat 1 and 2)

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Justification for classification or non-classification

According to OECD 439:2015, under the test conditions applied, the test substance is NOT considered SKIN IRRITANT.

Under the test method OECD 492:2018 and test conditions , it is concluded that the test item was Irritant.

According to the test method , the test substance is considered as requiring further testing for resolving between UN GHS categories 1 and 2.

Basing on the result of the test according to OECD 439; on that the substance ha not an extreme pH (from 6 to 8) the substance is classifed as EYE IRRITANT (GHS category 2).